By Amit Dhawan, MD, and Michael Fronstin, Kantar Health

Pain is a large and growing market globally, affecting more than 1 billion people worldwide. It is a high-prevalence, low-diagnosis market and often results in extremely high unmet needs. As anyone who experiences pain, either chronically or acutely, can tell you, it is incredibly difficult to treat because everybody experiences it differently, and the many different types of pain add another layer of complexity.

An ethnic group is defined as a group of people who identify with each other based on intrinsic factors, such as genetic similarities due to common ancestry, and extrinsic factors, such as shared cultural experiences or environment.  Therefore, one’s ethnicity is a fundamental aspect of life that defines a person, and that differentiates that person from others. 

Ethnic differences have become important in the field of clinical drug development because they may impact the absorption, distribution, metabolism, or excretion (ADME) of drugs, and may be relevant to an understanding of a drug’s efficacy and safety.        

Inter Partes Review (IPR), introduced by the America Invents Act (AIA), opens the door to another venue and procedure to challenge the validity of a patent. IPR on pharmaceutical patents is drawing increasing attention as an additional threat for a research-based (brand) pharmaceutical company facing or already involved in Hatch-Waxman litigation—the most common type of patent litigation between brands and generics seeking to market copies of branded products. 

Overview of Hatch-Waxman
Litigation and IPR 

Hatch-Waxman litigation typically occurs between a brand company, which holds a New Drug Application (NDA) to sell a drug, and a generic, which files an Abbreviated New Drug Application (ANDA) requesting FDA approval to market a generic copy of the NDA holder’s drug.